BACKGROUND: Many infectious diseases that cause significant morbidity and mortality, especially in the developing world, could be preventable through vaccination. The effort to produce safe, thermally stable, and needle-free mucosal vaccines has become increasingly important for global health considerations. We have previously demonstrated that a thermally stable nanoemulsion, a mucosal adjuvant for needle-free nasal immunization, is safe and induces protective immunity with a variety of antigens, including recombinant protein. The successful use of nanoemulsion-based vaccines, however, poses numerous challenges. Among the challenges is optimization of the formulation to maintain thermal stability and potency and another is accuracy and efficiency of dispensing the vaccines to the nasal mucosa in the anterior and turbinate region of the nasal cavity or potentially to the nasopharynx-associated lymphoid tissue. METHODS: We have examined the effects of different diluents [phosphate-buffered saline (PBS) and 0.9% NaCl] on the stability and potency of nanoemulsion-based vaccines. In addition, we have determined the efficiency of delivering them using commercially available nasal spray devices (Pfeiffer SAP-62602 multidose pump and the BD Hypak SCF 0.5 ml unit dose Accuspray(TM)). RESULTS: We report the stability and potency of PBS-diluted ovalbumin-nanomeulsion mixtures for up to 8 months and NaCl-diluted mixtures up to 6 months when stored at room temperature. Significant differences in spray characteristics including droplet size, spray angle, plume width, and ovality ratios were observed between the two pumps. Further, we have demonstrated that the nanoemulsion-based vaccines are not physically or chemically altered and retain potency following actuation with nasal spray devices. Using either device, the measured spray characteristics suggest deposition of nanoemulsion-based vaccines in inductive tissues located in the anterior region of the nasal cavity. CONCLUSIONS: The results of this study suggest that nanoemulsion-based vaccines do not require specially engineered delivery devices and support their potential use as nasopharyngeal vaccine adjuvants.
BACKGROUND: Many infectious diseases that cause significant morbidity and mortality, especially in the developing world, could be preventable through vaccination. The effort to produce safe, thermally stable, and needle-free mucosal vaccines has become increasingly important for global health considerations. We have previously demonstrated that a thermally stable nanoemulsion, a mucosal adjuvant for needle-free nasal immunization, is safe and induces protective immunity with a variety of antigens, including recombinant protein. The successful use of nanoemulsion-based vaccines, however, poses numerous challenges. Among the challenges is optimization of the formulation to maintain thermal stability and potency and another is accuracy and efficiency of dispensing the vaccines to the nasal mucosa in the anterior and turbinate region of the nasal cavity or potentially to the nasopharynx-associated lymphoid tissue. METHODS: We have examined the effects of different diluents [phosphate-buffered saline (PBS) and 0.9% NaCl] on the stability and potency of nanoemulsion-based vaccines. In addition, we have determined the efficiency of delivering them using commercially available nasal spray devices (Pfeiffer SAP-62602 multidose pump and the BD Hypak SCF 0.5 ml unit dose Accuspray(TM)). RESULTS: We report the stability and potency of PBS-diluted ovalbumin-nanomeulsion mixtures for up to 8 months and NaCl-diluted mixtures up to 6 months when stored at room temperature. Significant differences in spray characteristics including droplet size, spray angle, plume width, and ovality ratios were observed between the two pumps. Further, we have demonstrated that the nanoemulsion-based vaccines are not physically or chemically altered and retain potency following actuation with nasal spray devices. Using either device, the measured spray characteristics suggest deposition of nanoemulsion-based vaccines in inductive tissues located in the anterior region of the nasal cavity. CONCLUSIONS: The results of this study suggest that nanoemulsion-based vaccines do not require specially engineered delivery devices and support their potential use as nasopharyngeal vaccine adjuvants.
Authors: Andrzej Myc; Jolanta F Kukowska-Latallo; Anna U Bielinska; Peter Cao; Piotr P Myc; Katarzyna Janczak; Tracy R Sturm; Michael S Grabinski; Jeffrey J Landers; Katherine S Young; Jennifer Chang; Tarek Hamouda; Michal A Olszewski; James R Baker Journal: Vaccine Date: 2003-09-08 Impact factor: 3.641
Authors: Anna U Bielinska; Alexander A Chepurnov; Jeffrey J Landers; Katarzyna W Janczak; Tatiana S Chepurnova; Gary D Luker; James R Baker Journal: Clin Vaccine Immunol Date: 2007-12-05
Authors: Anna U Bielinska; Paul E Makidon; Katarzyna W Janczak; Luz P Blanco; Benjamin Swanson; Douglas M Smith; Tiffany Pham; Zsuzsanna Szabo; Jolanta F Kukowska-Latallo; James R Baker Journal: J Immunol Date: 2014-02-14 Impact factor: 5.422
Authors: Jessica J O'Konek; Paul E Makidon; Jeffrey J Landers; Zhengyi Cao; Carrie-Anne Malinczak; Jessie Pannu; Jennifer Sun; Vira Bitko; Susan Ciotti; Tarek Hamouda; Zbigniew W Wojcinski; Nicholas W Lukacs; Ali Fattom; James R Baker Journal: Hum Vaccin Immunother Date: 2015 Impact factor: 3.452
Authors: Yongyi Fan; Rui Guo; Xiangyang Shi; Steven Allen; Zhengyi Cao; James R Baker; Su He Wang Journal: Nanomaterials (Basel) Date: 2016-11-25 Impact factor: 5.076